New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen

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New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen
  100% of Insulin Doses Administered Were Delivered Within Pre-Determined
                 Guidelines and Standard Dosing Limitations

    BRIDGEWATER, N.J., May 5 /PRNewswire-FirstCall/ -- A new study
examining the dose accuracy of the SoloSTAR(R) disposable insulin pen,
prefilled with Lantus(R) (insulin glargine [rDNA origin] injection) or
Apidra(R) (insulin glulisine [rDNA origin] injection), found the pens
accurately delivered all insulin doses within standard limits defined by
the International Organization for Standardization (ISO). Lantus(R)
SoloSTAR(R) was approved by the U.S. Food and Drug Administration (FDA) on
April 25, 2007. Apidra(R) for use in the SoloSTAR(R) prefilled disposable
pen is currently under review at the FDA. The study, presented on May 2,
2008 at the 43rd Congress of the German Society for Diabetes (DDG) in
Munich, Germany, examined the accuracy of both pens at multiple target
dosages to determine the proportion of doses that fell within ISO ranges.

    "For people with diabetes who use an insulin pen to deliver their
insulin, dose accuracy is essential for their treatment," stated Norbert
Hermanns, Ph.D., director of the Research Institute of the Diabetes Academy
Mergentheim, Bad Mergentheim, Germany, and lead investigator in the study.
"Based on the findings of this study, we concluded that the SoloSTAR(R) pen
is an accurate insulin delivery option for people with diabetes."

    The study participants, a random sample of 60 hospital inpatients with
type 1 and type 2 diabetes, were trained on correct use of the SoloSTAR(R)
pen. Participants were then asked to inject three target doses with
Lantus(R) into an insulin-sponge, in doses of 10 (low), 40 (medium) and 80
(high) units, and three doses of Apidra(R) in doses of 5 (low), 15 (medium)
and 30 (high) units. The quantity of insulin delivered was calculated by
the weight of the insulin pens before and after injection. The order of the
dosages was randomized. All doses (100%) were within the limits prescribed
by the ISO standard (mean doses were only 0.9% to 1.3% below targets for
Lantus(R), and 0.4% to 1.1% below targets for Apidra(R)), and the data set
was within the ISO-defined 97.5% confidence intervals at each dose.

    About Diabetes

    Diabetes is a chronic, widespread condition in which the body does not
produce or properly use insulin, the hormone needed to transport glucose
(sugar) from the blood into the cells of the body for energy. More than 230
million people worldwide are living with the disease and this number is
expected to rise to a staggering 350 million within 20 years. It is
estimated that more than 20 million Americans have diabetes, including an
estimated 6.2 million who remain undiagnosed. At the same time,
approximately half of those diagnosed are not achieving the general blood
sugar control standard of A1C <7 percent recommended by the American
Diabetes Association (ADA). The A1C test measures average blood glucose
levels over a two- to three-month period.

    About sanofi-aventis

    Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).



     U.S. Contacts:
     Carrie Melia
     Carrie.Melia@sanofi-aventis.com
     908-981-6486

    US.GLA.08.05.001
SOURCE sanofi-aventis
http://www.sanofi-aventis.us
http://www.sanofi-aventis.com
http://www.prnewswire.com/comp/232375.html /
CONTACT:
Carrie Melia of sanofi-aventis,
+1-908-981-6486, Carrie.Melia@sanofi-aventis.com